Leucocytes (inflammatory cells) elaborated in the gingival sulcus, present in the oral cavity and/or on the surface of oral tissues play a major, and possible the primary role in the natural host defense system for preventing infection and various oral diseases and malfunctions resulting from the presence of microorganisms and their toxins in the oral cavity and/or from the presence of bacteria in the oral cavity. Ninety-nine percent of these inflammatory cells are polymorphonuclear neutrophils (PMN).
A study of 18 human subjects (male and female, ranging in age from 15 to 60, each having at least 20 teeth) illustrates the order of magnitude of this first line of body defense. Oral lavages were collected from each subject by chewing paraffin for thirty seconds in the presence of a physiologically compatible fluid environment. This yielded ubiquitous PMN of host oral origin ranging from 5 million to 33 million per ml. of hose fluid (saliva, gingival exudate, etc.) contribution contained in such lavages. For a more detailed and informative basis for these findings, see, for example, our prior publications: Journal of Dental Research, Vol. 40, 1961, p. 747; Journal of the American Society of Periodontists, Vol. 1, No. 3, May/June, 1963, pp. 109-117; Archives of Oral Biology, Vol. 9, 1964, pp. 299-314; Journal of Society of Cosmetic Chemistry, Vol. 15, 1964, pp. 149-154; Dental Abstracts, October, 1964, p. 651; Annals New York Academy of Science, Vol. 131, Art. 2, 1965, pp. 812-814 and 851-867; Science, Vol. 166, pp. 1424-1428; and Archives of Oral Biology, Vol. 18, 1973, pp. 505-516, all of which are incorporated by reference herein.
The advantages, if not the necessity, for keeping these leucocytes healthy, e.g., viable, active, locomoting, phagocytizing and capable of killing bacteria will be readily apparent. It will be equally as apparent that, where possible, one must avoid hinderance of these vital body defense cells and their mechanisms so as not adversely to affect maintenance of their normal healthy functional state.
The ideal condition in humans is for these oral leucocytes to remain and to be maintained in a healthy, viable state so as to be able to perform their function as a prime body defense mechanism. In other words, the normal and optimum condition is for these oral leucocytes to exist in that state nature intended.
Thus, for example, as reported in Archives of Oral Biology, Vol. 9, 1964, pp. 299-314, and Science, Vol, 166, 1969, pp. 1424-1428, it has been consistently observed that properly prepared oral lavages obtained from healthy humans contain large number of peripheral-wandering oral leuocytes which are intact, alive and functional. In such typical harvests, many of the leucocytes, free or contained in clusters, locomote, vigorously extend pseudopodia, exhibit protoplasmic flow, cell stretching and movement of cell organelles internally. These leucocytes also frequently phagocytize (actively engulf) large rod, chain, filamentous, or other microorganisms. (These important functions of these essential cells of the body defense system have been recorded dramatically by us in time laspe motion picture films.)
While this is the healthy state, humans in general in most instances do not maintain environmental conditions in the oral cavity favoring healthy, viable ubiquitous leucocytes. Thus, due to such factors as the ingestion or oral application of substances or complexes of substances which are nonphysiological in nature, i.e., substances which nature did not intend humans to ingest or be exposed to such as conventional toothpastes and mouth washes, tobacco smoke, high concentration alcoholic beverages, etc., which factors are in general peculiar to civilized humans as distinguished from other members of the animal kingdom, the environment of these Leucocytes is so altered as to interfere with their normal, healthy function, and, in turn, their body defense role.
By way of illustration, oral lavages sampled from healthy individuals with protective leucocyte lavage solution-toothpaste extracts, or with protective leucocyte lavage solution-mouthwash extracts (the tooth pasted and mouthwashes having been purchased over the counter at drugstores), or with non-protective leucocyte lavage solutions have been observed to contain damaged, fragmenting and fragmented leucocytes. By way of further illustration, oral lavages collected with protective leucocyte solutions from healthy individuals after smoking one cigarette without inhaling contain, after harvesting, isolated leucocytes and clusters of leucocytes which: (1) appear to verge on the brink of locomotion and possibly phagocytosis, but remain incapable of overcoming the locomotion and phagocytosis-inhibiting effect provided by their environment; (2) at the periphery and within some of the clusters are rounded and their granules exhibit active brownian motion, one example of damaged leucocytes; (3) vigorously form blebs or vesicles (bubble blowing), other examples of toxicity, while they may attempt to locomote very sluggishly and also attempt feeble phagocytosis without success; (4) are obviously injured to the point where they are inert or fragmented. Many of these observations, which are perhaps lacking in drama when observed under the microscope, also have been recorded in time lapse photomicrography motion pictures. Such sequences, in fact, are visually quite boring as distinguished from those sequences of the activities of viable, healthy leucocytes. The respective effects can be observed experimentally for some hours after the environmental condition has been established.
Since the role in body defense played by ubiquitous leucocytes (such as those present in the oral cavity) has heretofore been well known, it was apparent that any inhibition, even a partial inhibition, of the functioning of these leucocytes for periods of time, would be detrimental to the health of the host individual and may, in fact, be a prime cause of diseases in the oral cavity and elsewhere. From what has been stated, it should also be apparent that any non-toxic, edible and digestible compositions which can be safely taken within and applied to the tissues of the oral cavity and which are capable of maintaining the proper environmental conditions which favor continuous functioning of oral leucocytes in the manner nature intended are inherently of considerable usefulness.
It is to such compositions and the maintenance of healthy functional leucocytes to which this invention is directed.